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Safety and tolerability of volplex((r)) in elective surgery
Robert J Sneyd1, Bernard C Dean, Colum Dwyer
1Peninsula Medical School, University of Plymouth, Plymouth, UK.
Clinical Drug Investigation
|May 23, 2007
Summary
This study found Volplex®, a new succinylated gelatin, to be comparable to Gelofusine® in safety and tolerability for patients undergoing elective surgery. Adverse events were similar between the two colloids, with none considered probably related to either product.
Area of Science:
- Medical Science
- Pharmacology
- Anesthesiology
Background:
- Succinylated gelatin is a common fluid resuscitation agent for hypovolemia.
- Volplex® is a novel presentation of succinylated gelatin in a collapsible bag, sterilized at 121°C.
- Gelofusine® is an established brand of succinylated gelatin used as a control.
Purpose of the Study:
- To evaluate the safety and tolerability of Volplex® compared to Gelofusine®.
- To assess Volplex® in patients undergoing elective surgery.
Main Methods:
- An open-label, randomized, parallel-group trial was conducted.
- 76 patients (18-75 years) were randomized in a 2:1 ratio to receive either Volplex® or Gelofusine®.
- Safety and tolerability were assessed preoperatively, perioperatively, and 24 hours post-induction.
Main Results:
- No significant differences in fluid volumes (crystalloids, blood) received between groups.
- Similar rates of possibly related adverse events: 44% for Volplex® and 53% for Gelofusine®.
- No adverse events were considered probably related to either colloid; one serious event (hypothermia) in the Gelofusine® group.
Conclusions:
- Volplex® demonstrated comparable safety and tolerability to Gelofusine® in this study.
- The new presentation of succinylated gelatin is suitable for managing hypovolemic conditions during elective surgery.
- Further research may be warranted to confirm findings in larger populations.
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